FDA Registration
Active
🇺🇸 United States
Gynesonics Sonata System Cart
Reg #: 3013875526
·
FEI: 3013875526
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Modo Inc.
- Registration Number
- 3013875526
- FEI Number
- 3013875526
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 18355 SW Teton Ave
- City
- Tualatin
- State
- OR
- ZIP
- 97062
- Country
- US
Regulatory Submissions
- 510(k) Number
- K173703
Owner / Operator
- Firm Name
- Modo Inc
- Operator Number
- 10042825
- Address
- 9025 NW von Neumann Drive, Suite 170
- City
- Hillsboro
- State
- OR
- Postal Code
- 97006
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Coagulator-Cutter, Endoscopic, Unipolar (And Accessories) | KNF | Class 2 | Obstetrics/Gynecology | No | 2018-11-05 |
Proprietary Names
Gynesonics Sonata System Cart
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)